Evaluating Palmitoylethanolamide for Bipolar Depression
A Randomized Controlled Trial of the Fatty Acid Amide Hydrolase Inhibitor Palmitoylethanolamide in Bipolar Depression
This study is testing if a supplement called Palmitoylethanolamide can help people with Bipolar Depression feel better compared to a placebo or standard treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06229977 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the antidepressant effects of Palmitoylethanolamide (PEA) in patients diagnosed with Bipolar Depression. It will also explore the relationship between the antidepressant response and levels of endogenous cannabinoids and cytokines. Participants will receive either PEA, a placebo, or treatment as usual, while their mood and biological markers will be monitored throughout the trial. The study is designed to provide insights into the efficacy of PEA as a potential treatment option for this condition.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Bipolar Disorder who are currently on at least one FDA-approved mood stabilizer and have moderate to severe depressive symptoms.
Not a fit: Patients with active substance use disorders, acute suicidal risk, or those experiencing manic episodes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new therapeutic option for patients suffering from Bipolar Depression.
How similar studies have performed: While the specific use of PEA in Bipolar Depression is novel, other studies have explored cannabinoid-based treatments with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnosis of Bipolar Disorder according to the Diagnostic and Statistical Manual of Mental Disorders (Structured Clinical Interview), Fifth Edition, (DSM5), with a score of ≥16 on the 17-item HAM-D * currently in use of at least one FDA approved mood stabilizer with or without antidepressant * medically and neurologically healthy on the basis of medical history, physical examination Exclusion Criteria: * Cannabis misuse according to clinical judgement * unstable medical condition or uncontrolled medical problem with known central nervous system (CNS) effects * active DSM-5 substance use disorder in past three months (other than alcohol or nicotine use disorder) * acute high suicidal risk * in a manic episode * current psychotic features or cognitive impairment that would preclude understanding of the consenting process or tests/examination * pregnant or nursing women * unstable medical conditions * clinically significant abnormal laboratory tests based on complete blood count, liver and kidney function when available
Where this trial is running
Houston, Texas
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Rodrigo Machado-Vieira, M.D, Ph.D., M.Sc — The University of Texas Health Science Center, Houston
- Study coordinator: Rodrigo Machado-Vieira, M.D, Ph.D., M.Sc
- Email: Rodrigo.MachadoVieira@uth.tmc.edu
- Phone: (713) 486-2581
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.